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01 2Dr. Reddy's Laboratories

02 4Alfred E Tiefenbacher GmbH

03 2Medichem S.A

04 3ABEX Pharmaceutica

05 2Actavis Inc

06 2Ajanta Pharma Limited

07 2Alkem Laboratories

08 2Alphapharm PTY Ltd

09 7Apotex Inc

10 2Bionpharma

11 2ENDO OPERATIONS

12 3Farm Agon

13 2Hetero Drugs

14 4Inventia Healthcare Limited

15 2Leading Pharma, LLC

16 2Lupin Ltd

17 2Mankind Pharma

18 4Nora Pharma

19 2Orchid Pharma

20 1Oyster Point Pharma

21 3Pfizer Consumer Healthcare

22 16Pfizer Inc

23 3Pharmacore Inc

24 2Piramal Pharma Solutions

25 2Teva Pharmaceutical Industries

26 2Viatris

27 2Zydus Lifesciences

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : RX

Registration Country : USA

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Packaging :

Approval Date : 2024-10-01

Application Number : 215931

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q3 2019

Registration Country : Germany

Varenicline

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q3 2019

Registration Country : Germany

Tiefenbacher Compnay Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

Regulatory Info :

Registration Country : Spain

Varenicline Tartrate

Brand Name :

Dosage Form : Tablet

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

Medichem

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : RX

Registration Country : USA

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Packaging :

Approval Date : 2024-10-01

Application Number : 215931

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q3 2019

Registration Country : Germany

Varenicline

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q3 2019

Registration Country : Germany

Tiefenbacher Compnay Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q3 2019

Registration Country : Germany

Varenicline

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q3 2019

Registration Country : Germany

Tiefenbacher Compnay Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q3 2019

Registration Country : Germany

Varenicline

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q3 2019

Registration Country : Germany

Tiefenbacher Compnay Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

Regulatory Info :

Registration Country : Spain

Varenicline Tartrate

Brand Name :

Dosage Form : Tablet

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

Medichem

09

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Packaging :

Approval Date :

Application Number : 201808

Regulatory Info :

Registration Country : USA

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10

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Packaging :

Approval Date :

Application Number : 201808

Regulatory Info :

Registration Country : USA

blank

11

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Packaging :

Approval Date : 2023-01-25

Application Number : 201962

Regulatory Info : RX

Registration Country : USA

blank

12

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Packaging :

Approval Date : 2023-01-25

Application Number : 201962

Regulatory Info : RX

Registration Country : USA

blank

13

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

VARENICLINE TARTRATE

Brand Name : CHANTIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2006-05-10

Application Number : 21928

Regulatory Info : DISCN

Registration Country : USA

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14

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

VARENICLINE TARTRATE

Brand Name : CHANTIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2006-05-10

Application Number : 21928

Regulatory Info : DISCN

Registration Country : USA

blank

15

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

VARENICLINE

Brand Name : VARENICLINE

Dosage Form : TABLET; ORAL

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number : 201920

Regulatory Info :

Registration Country : USA

blank

16

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

VARENICLINE

Brand Name : VARENICLINE

Dosage Form : TABLET; ORAL

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number : 201920

Regulatory Info :

Registration Country : USA

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17

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Packaging :

Approval Date : 2024-02-28

Application Number : 202019

Regulatory Info : RX

Registration Country : USA

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18

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Packaging :

Approval Date : 2024-02-28

Application Number : 202019

Regulatory Info : RX

Registration Country : USA

blank

19

ENDO OPERATIONS

Country
euroPLX 86 Munich
Not Confirmed
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ENDO OPERATIONS

Country
arrow
euroPLX 86 Munich
Not Confirmed

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Packaging :

Approval Date : 2021-08-11

Application Number : 201785

Regulatory Info : RX

Registration Country : USA

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20

ENDO OPERATIONS

Country
euroPLX 86 Munich
Not Confirmed
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ENDO OPERATIONS

Country
arrow
euroPLX 86 Munich
Not Confirmed

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Packaging :

Approval Date : 2021-08-11

Application Number : 201785

Regulatory Info : RX

Registration Country : USA

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